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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034799
Receipt No. R000039667
Official scientific title of the study Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/20

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Basic information
Official scientific title of the study Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Title of the study (Brief title)
Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We evaluate improvement of surgical outcome of resection both tumor and thrombus by presurgical treatment with pazopanib in patients with advanced renal cell carcinoma (RCC) with inferior vena cava tumor thrombus.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bleeding volume in surgery
Key secondary outcomes -Improvement of surgical invasion: Outcome of change from surgical procedure expected before surgery to minimally invasive surgical procedure due to tumor reduction.
-Operation time
-Grade 3 or higher complications
-Reduction in the level of tumor embolism according to the classification of Mayo clinic
-Reduction rate of primary tumor and metastatic lesion.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 12 weeks oral administration of pazopanib.
Surgical excision of tumor and thrombus within 7 days and 21 days from the end date of pazopanib administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Renal cell carcinoma with tumor thrombus
2.Tumor thrombus which reach Inferior vena cava
3.Written informed consent
Key exclusion criteria 1.Patients who did not participate in this study
2.Patients who participated in other clinical trials within 4 months.
3.Performance Status> 3
4.AST,ALT> 3.0*upper limit of normal range(ULN), or total Bil> 2.0*ULN
5.Patients who receive treatment of other cancer
Target sample size 25

Research contact person
Name of lead principal investigator Tomoaki Terakawa
Organization Kobe University Graduate School of Medicine
Division name Urology
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN,
TEL 0783826155
Email daatera0804@yahoo.co.jp

Public contact
Name of contact person Yasuyoshi Okamura
Organization Kobe university Graduate School of Medicine
Division name Urology
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN,
TEL 0783826155
Homepage URL
Email dfgky008@gmail.com

Sponsor
Institute Kobe university Graduate School of Medicine Division of Urology
Institute
Department

Funding Source
Organization Kobe university Graduate School of Medicine
Division of Urology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 神戸大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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